Gender Differences in Transfemoral TAVR

Study Questions:

Are there differences in outcomes between men and women undergoing transfemoral transcatheter aortic valve replacement (TAVR)?

Methods:

This was a retrospective analysis from the global CENTER collaboration of >12,000 TAVR patients from 2007-2018. In-hospital outcomes of mortality, stroke, myocardial infarction, new-onset atrial fibrillation, and permanent pacemaker (PPM) implantation and 30-day rates of stroke and mortality were evaluated. Temporal trends in mortality over the study period were compared between men and women.

Results:

The study included 12,381 patients (women = 7,120; men = 5,261) who underwent transfemoral TAVR. In-hospital and 30-day outcomes were similar for stroke (2.0% vs. 2.0%, p = 0.93 and 2.3% vs. 2.5%, p = 0.53, respectively) and mortality (5.2 vs. 4.6%, p = 0.14 and 5.9% vs. 5.5%, p = 0.17, respectively) in women and men, respectively. Men were more likely to need PPM placement. Women had a 50% higher rate of major or life-threatening bleeding compared to men (6.7% vs. 4.4%; p < 0.01), and in women, this was inversely related to body mass index. Both women and men saw improvement in mortality rates over time (50% vs. 60% reduction), although women had less improvement over time. Stroke rates did not change over time.

Conclusions:

Women and men undergoing TAVR have similar rates of in-hospital and 30-day stroke and mortality. Women have a 50% higher rate of major bleeding compared to men. Mortality rates improved to a slightly greater degree in men over time compared to women.

Perspective:

This is a large patient-level analysis exploring trends in outcomes among men and women undergoing TAVR over a decade. Women appear to be slightly older (1 year) with less overall comorbidities (except hypertension and lower renal clearance). Outcomes of stroke and mortality are similar between men and women. In concordance with sex-based differences in bleeding seen in patients undergoing percutaneous coronary intervention (PCI) and coronary artery bypass grafting, women undergoing TAVR had a two-fold higher risk of major bleeding. Although the types of bleeding were not captured in this study (access-site vs. non–access-site), women in general have been noted to be at increased risk for both in the PCI literature. Interplay between differences in body mass composition, anatomy, creatinine clearance, appropriate anticoagulation dosing, and other unmeasured differences most likely contribute to the excess bleeding risk seen in women. Application of bleeding avoidance strategies such as optimizing access site techniques (ultrasound guidance), using radial access for secondary access, and applying cautious anticoagulation targets may help lower the excess bleeding risk seen in women undergoing TAVR. Whether the higher bleeding rates in women are responsible for less improvement in mortality over time remains to be determined.

Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Body Mass Index, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Myocardial Infarction, Outcome Assessment, Health Care, Pacemaker, Artificial, Percutaneous Coronary Intervention, Risk, Secondary Prevention, Stroke, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics, TCT19


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